Oral Microbiome in Carotid Atherosclerosis

Summary

The goal of this observational study, called OMICA (Oral Microbiome in Carotid Atherosclerosis), is to learn how bacteria living in the mouth may influence the development and stability of plaques in the carotid arteries, which supply blood to the brain. Plaque buildup in these arteries can lead to stroke.

Researchers want to understand whether certain oral bacteria are linked to plaque vulnerability, meaning a higher chance that the plaque will rupture and cause a stroke.

The study will include a cohort of adults scheduled for carotid endarterectomy at Semmelweis University. Participants will be enrolled in the Semmelweis University Carotid Biobank project.

The main questions the study aims to answer are:

Do people with more severe gum disease or tooth infection have a higher number of bacteria in their carotid plaques, and are those plaques more likely to rupture?

Are the bacteria found in vulnerable plaques different from those in stable plaques?

Are similar bacteria found in the mouth, gut, and plaques, suggesting that bacteria may travel through the body?

What participants will do:

Have their oral health checked before surgery, including an exam of gum disease and tooth infections.

Provide microbiome samples from the mouth, anus, urine, and carotid plaque (taken during surgery).

Have preoperative photon-counting computed tomography (CT) performed to assess plaque stability and study eligibility.

All samples and imaging data will be analyzed to identify bacterial species and their relationship to plaque type.

The study does not involve any experimental treatment or medication. Participation adds no significant medical risk beyond standard care.

Researchers will compare bacterial patterns between people with vulnerable plaques and those with stable plaques to identify microbial signatures linked to carotid plaque instability.

The results may help create future microbiome-based risk models for detecting people at higher risk of stroke or severe atherosclerosis.

Conditions

• Atherosclerosis Cardiovascular Disease
• Atherosclerosis of Artery
• Carotid Artery Plaque
• Periodontitis
• Carotid Artery Diseases

Interventions

OTHER

Sample Collection

Participants undergo preoperative oral health evaluation and the collection of oral, anal, urine, blood, and carotid plaque samples during carotid endarterectomy for microbiome analysis. All samples are fully anonymized and processed within the Semmelweis University Carotid Plaque Biobank (BM/33955-1/2023). No experimental treatments are administered; all activities occur within the framework of biobank-approved surgical and diagnostic procedures.

Sponsors & Collaborators

• National Research, Development and Innovation Office, Hungary

  collaborator UNKNOWN

• Semmelweis University Heart and Vascular Center

  lead OTHER

Principal Investigators

• Péter Sótonyi, MD, DSc · Semmelweis University Heart and Vascular Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2027-11-01

Completion

2029-11-01

Countries

• Hungary

Study Locations